Nivolumab-Sutent Scan update

Darron

Scan today still showed a mildly swollen adrenal gland. The question we are not sure of: Is it scar tissue from having the 3.8 cm tumor in the gland, or is it still a touch if cancer still remaining. The treatment for the next 12 weeks is to continue with Nicolumab infusions for every 3 weeks. We have dropped Sutent from the program and hope that it doesn't impact the shrinkage That we have seen so far. Any thoughts on subject are appreciated. We are happy with the news, but we were hoping to meet NED today, so there is a little anticlimax.

Ill keep being the site stalker and chime in when I feel my experiences are relevant. 

Keep fighting!

 

alice124

So you may be NED but not

So you may be NED but not know it yet? That's what I'm reading (and hoping).

Sorry, I can't offer any thoughts but I guess I don't understand the discontinuation of Sutent. (Sorry if I've missed something you wrote earlier.) What's the rationale? And I didn't think they could modify given you are in trial. Sorry to be asking questions rather than answering.

foxhd

alice124 said:

So you may be NED but not

So you may be NED but not know it yet? That's what I'm reading (and hoping).

Sorry, I can't offer any thoughts but I guess I don't understand the discontinuation of Sutent. (Sorry if I've missed something you wrote earlier.) What's the rationale? And I didn't think they could modify given you are in trial. Sorry to be asking questions rather than answering.

Sounds great to me.

The nivolumab seems to be doing it's thing. Without the combo, you have so much fewer side effects. I like where you're going. It takes a while. Live on Darron.

Limelife50

Hi Darron

I guess we can give your latest report a PG rating as in pretty good,it seems as though you are as about as close to NED as you can get.

Darron

alice124 said:

So you may be NED but not

So you may be NED but not know it yet? That's what I'm reading (and hoping).

Sorry, I can't offer any thoughts but I guess I don't understand the discontinuation of Sutent. (Sorry if I've missed something you wrote earlier.) What's the rationale? And I didn't think they could modify given you are in trial. Sorry to be asking questions rather than answering.

Rationale

we are hoping I am NED, But cant say that for sure. We don't have a base line of my adrenal gland since it has had a tumor since my 1st scan. So there is no way to say with certainty that there is no visible evidence of disease. It could be gone and the swelling is my natural state. It could be gone and there is scaring from having the tumor in the gland. ...And it could be a small trace of remaining cancer. The rationale is to eliminate the Sutent and monitor in 12 weeks. That will help identify that it is the Nivolumab that is the active agent. If it grows in 12 weeks, bring the Sutent back in. Since the Sutent was causing more side effects, it is a welcome change. In 12 weeks, if I am still stable or if I see reduced swelling, they will discuss ending the infusions and begin monitoring only. My impression is that this is the first step in finishing the trial. It could also be the beginning of maintenance dosing. The trial has changed a bit and hey seem to be responding to my situation vs. following a severly strict protocol. That is actually refreshing to see.

it was a difficult day mentally. Getting so close, yet still having doubt of what is really happening. Additionally, it seems I had a bit of an allergic reaction to the contrast, so the infusion was delayed until the reaction subsided (Tingling tongue, lump in throat)

i know the trial provides a lot of hope for a cure, so I want to share. It seems to be working for me. I will continue to keep all posted. I am hoping someone out there may have experienced a similar situation, maybe even from IL-2?

It may be that I am all shrunken out, Alice. Dont hold it against me that I don't have any more shrinkage to offer you!

Fight on!!!

Darron

alice124 said:

So you may be NED but not

So you may be NED but not know it yet? That's what I'm reading (and hoping).

Sorry, I can't offer any thoughts but I guess I don't understand the discontinuation of Sutent. (Sorry if I've missed something you wrote earlier.) What's the rationale? And I didn't think they could modify given you are in trial. Sorry to be asking questions rather than answering.

Sutent

Droping the Sutent was a surprise to me. I think the required dose for the trial has been met thru my previous cycles....I didn't ask too many why's in that area, so it is only speculation. I think this is a new and unique situation for the trial team as well. I am sure there will be more info and discussions at my next infusion in 3 weeks.

it was also discussed that I may be asked to continue dosing as maintenance. Again, speculation, I will share any new info I get.

BDS

Nivolumab

 

Darron, Best of luck on you becoming NED. However, the doctors are probably going to require several confirmation scans before they will truly pronounce you NED.  This is going to be take time but you have already made awesome progress.  You are very lucky to get into this clinical trial. Right now the earliest that may be FDA may approve nivolumab will be late 2014 or early 2015. Let’s hope this trial makes FDA approval a reality. - BDS  

 

foxhd

BDS said:

Nivolumab

 

Darron, Best of luck on you becoming NED. However, the doctors are probably going to require several confirmation scans before they will truly pronounce you NED.  This is going to be take time but you have already made awesome progress.  You are very lucky to get into this clinical trial. Right now the earliest that may be FDA may approve nivolumab will be late 2014 or early 2015. Let’s hope this trial makes FDA approval a reality. - BDS  

 

Nice Darron!

This nivolumab is the ticket for many. I hope tobe able to restart it when I need my next drug. I'll bet the response would be awesome after the IL-2. I think one putt would agree.

AprilandChuck

Darron said:

Sutent

Droping the Sutent was a surprise to me. I think the required dose for the trial has been met thru my previous cycles....I didn't ask too many why's in that area, so it is only speculation. I think this is a new and unique situation for the trial team as well. I am sure there will be more info and discussions at my next infusion in 3 weeks.

it was also discussed that I may be asked to continue dosing as maintenance. Again, speculation, I will share any new info I get.

Nivolumab

We go in Monday to see Dr Amin and finally recieve Chucks full scan resu.ts from his last scan..as you know Chuck was on the Nivolumab IPI combo trial..his dosing for the Ipi portion ended months ago..he has bee recieving Nivolumab only..I am taking your scan results for the awesome news they are:-) its NED light lol..meaning instead of saying there is still tumor present they are saying we dont know what that is yet...Nivolumab has a lot less side effects than the Sud..any victory no matter how small it is needs to be celebrated! So far in this war you are winning battles..that is whats needed to successfully win a war! Congrats on the scan results! 

AprilandChuck

alice124 said:

So you may be NED but not

So you may be NED but not know it yet? That's what I'm reading (and hoping).

Sorry, I can't offer any thoughts but I guess I don't understand the discontinuation of Sutent. (Sorry if I've missed something you wrote earlier.) What's the rationale? And I didn't think they could modify given you are in trial. Sorry to be asking questions rather than answering.

Alice, 
There is some leeway

Alice, 

There is some leeway in this trial because of the multi arm nature..our info packet states that the trial dr may be able to keep you on Nivolumab..even if the other drugs cause to many side affects..that continuing with Nivolumab will be at the Drs discretion...I asked the Dr about the phrasing of that back when the trial started since our reason for wanting in was access to Nivolumab..now the next portion gets iffy..the trial is wanting people in 2 catagories removed..the first new growth..the sec absence of new growth and a total reduction of tumor load..the first is self explanatory. The second is open to interpretation...for example at Chucks previous scan not this past one..we don't have those results yet..Chuck tumor load was greatly reduced to almost nonexistent...however there was still a stable but enlarged lymphnode..and some shaddows that they were reading as scarring..which causedcthe Dr to keep Chuck on the trial..we get thecresults from his scan 2 wks ago tomorrow a cursory review of the scan no Radiology report at that time was in...showed the same enlargement and shadows present..we are waiting for the report to confirm..and make sure nothing else cropped up..if thats the case Dr Amin will prob chose to keep Chuck on the Nivolumab at least till his next scans...if the shadowing is gone and the lymphnode remains stable no new growth detected they will remove him from the trial..because of the fear of toxicity...as Dr Amin told us..they don't know whats enough and whats to much..not enough can be hazardous and so can to much! So as of last appointment they instated a very low threshold for side affects in Chucks case..Darron has the same Dr..different arm of the trial..he is very cautious..I guess my point is therecis some wiggle room in the trial for patients who are showing great response..but the Dr isnt sure if its actually total response..or for patients who suffer severe untreatable side affects assoiciated with the drug thats not Nivolumab...in other news Nivolumab is now being tested in other forms of cancer in a larger way! 

angec

foxhd said:

Nice Darron!

This nivolumab is the ticket for many. I hope tobe able to restart it when I need my next drug. I'll bet the response would be awesome after the IL-2. I think one putt would agree.

It sounds like GREAT news to

It sounds like GREAT news to me Darron!  I was just wondering. When taking Nivolumab does one lose weight like they do on Votrient? What is the Gov't waiting for to make this available to everyone?  Any idea when that day will come? Seems like the trials have been running somewhere like 2+ years already.  Keep up the good work and glad that it is helping you!

Darron

angec said:

It sounds like GREAT news to

It sounds like GREAT news to me Darron!  I was just wondering. When taking Nivolumab does one lose weight like they do on Votrient? What is the Gov't waiting for to make this available to everyone?  Any idea when that day will come? Seems like the trials have been running somewhere like 2+ years already.  Keep up the good work and glad that it is helping you!

No weight loss

I have heard 2013-201aaas possible approval, and that is a rush from the normal process. I think they have open slots as they have expanded to many different new arms (as April said). I think the issue is the locations. There are not too many sites. I know one person who is driving 7 hours for the trial From South Georgia to Charlotte.

From my experiences, the Nivo has very few side effects. immediately following the infusion, I will get a mild fever for 4-6 hours, but I usually sleep it off and feel fine for work the next day. 

as far as weight loss, the Sutent kept me feeling a little off. The Nivo has nhad given me any problems at all. I had surgery in Oct 2012. I went into the Surgery at 190lbs. within a few months, I dropped to as low as 160 When I started te trial. I am now back up to 180. Since I am now off the Sutent, I will start exercising a bit more and hopefully drop a few pounds and get in a little better shape.

search for the trial sites, I am not sure where they are located.

angec

Darron said:

No weight loss

I have heard 2013-201aaas possible approval, and that is a rush from the normal process. I think they have open slots as they have expanded to many different new arms (as April said). I think the issue is the locations. There are not too many sites. I know one person who is driving 7 hours for the trial From South Georgia to Charlotte.

From my experiences, the Nivo has very few side effects. immediately following the infusion, I will get a mild fever for 4-6 hours, but I usually sleep it off and feel fine for work the next day. 

as far as weight loss, the Sutent kept me feeling a little off. The Nivo has nhad given me any problems at all. I had surgery in Oct 2012. I went into the Surgery at 190lbs. within a few months, I dropped to as low as 160 When I started te trial. I am now back up to 180. Since I am now off the Sutent, I will start exercising a bit more and hopefully drop a few pounds and get in a little better shape.

search for the trial sites, I am not sure where they are located.

Thanks for the info, Darron.

Thanks for the info, Darron. I am glad you are doing well!

alice124

AprilandChuck said:

Alice, 
There is some leeway

Alice, 

There is some leeway in this trial because of the multi arm nature..our info packet states that the trial dr may be able to keep you on Nivolumab..even if the other drugs cause to many side affects..that continuing with Nivolumab will be at the Drs discretion...I asked the Dr about the phrasing of that back when the trial started since our reason for wanting in was access to Nivolumab..now the next portion gets iffy..the trial is wanting people in 2 catagories removed..the first new growth..the sec absence of new growth and a total reduction of tumor load..the first is self explanatory. The second is open to interpretation...for example at Chucks previous scan not this past one..we don't have those results yet..Chuck tumor load was greatly reduced to almost nonexistent...however there was still a stable but enlarged lymphnode..and some shaddows that they were reading as scarring..which causedcthe Dr to keep Chuck on the trial..we get thecresults from his scan 2 wks ago tomorrow a cursory review of the scan no Radiology report at that time was in...showed the same enlargement and shadows present..we are waiting for the report to confirm..and make sure nothing else cropped up..if thats the case Dr Amin will prob chose to keep Chuck on the Nivolumab at least till his next scans...if the shadowing is gone and the lymphnode remains stable no new growth detected they will remove him from the trial..because of the fear of toxicity...as Dr Amin told us..they don't know whats enough and whats to much..not enough can be hazardous and so can to much! So as of last appointment they instated a very low threshold for side affects in Chucks case..Darron has the same Dr..different arm of the trial..he is very cautious..I guess my point is therecis some wiggle room in the trial for patients who are showing great response..but the Dr isnt sure if its actually total response..or for patients who suffer severe untreatable side affects assoiciated with the drug thats not Nivolumab...in other news Nivolumab is now being tested in other forms of cancer in a larger way! 

Thanks April and Darron for

Thanks April and Darron for the explanation. I was puzzled with the flexibility in your trials. John's doctor seems to run a much tighter regime but that may simply be because he hasn't had the need to change course. Other than missing one infusion due to glass nodules in the lungs and a week or so off Votrient, he has been pretty much trial texbook for the 17 months he has been on it. I went back and read his latest Reseach Participant Informed Consent and Privacy Authorization Form and didn't note any wiggle room verbage. Are Chuck and Darron both in Phase one trials?

We're always interested what the next step might be should something change. That doesn't mean we won't be thrilled if it continues as is indefinitely, but always keeping our eyes open.  I guess with a scan this week we're opening our eyes even wider than usual.

Again thanks for explanation.

 

 

 

 

AprilandChuck

alice124 said:

Thanks April and Darron for

Thanks April and Darron for the explanation. I was puzzled with the flexibility in your trials. John's doctor seems to run a much tighter regime but that may simply be because he hasn't had the need to change course. Other than missing one infusion due to glass nodules in the lungs and a week or so off Votrient, he has been pretty much trial texbook for the 17 months he has been on it. I went back and read his latest Reseach Participant Informed Consent and Privacy Authorization Form and didn't note any wiggle room verbage. Are Chuck and Darron both in Phase one trials?

We're always interested what the next step might be should something change. That doesn't mean we won't be thrilled if it continues as is indefinitely, but always keeping our eyes open.  I guess with a scan this week we're opening our eyes even wider than usual.

Again thanks for explanation.

 

 

 

 

same phase 1 different arms

Alice, 

 Chuck and Darron have the same Oncologists and are in the same trial just different arms of it..Chuck is in the Nivolumab+Ipilumamab, Darron is In the Sutenet+Nivolumab arm..both Phase 1.. in Chucks arm ipi is only called for in 4 doses..over 2 cycles in combo with Nivolumab...Nivolumab. .then becomes the Maintenance drug for the remainder of the trial...but I rechecked our Trial Packet..it say that a patient may remain on Nivolumab only , at the trial Drs discretion...so your trial must be slightly different in rules than the one they are on..praying for you all to get wonderful scan results! Huggss